Needle device having slideable member providing enhanced safety

ABSTRACT

A medical device, such as a Huber-type device, includes a structure that enhances operator safety by reducing the likelihood that a needle will accidentally injure an operator. In one embodiment, the device includes a collapsible structure that can move from a use position to a non-use position. The device includes first and second wing portions and a channel for covering the needle as it is extracted from the patient. The structure enables the operator to leverage applied pressure for a smooth removal of the needle into the device for safe disposal.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.12/264,509, filed Nov. 4, 2008, which application is a Continuation ofU.S. patent application Ser. No. 10/712,600, filed Nov. 13, 2003, whichapplication is a Continuation-in-Part of U.S. patent application Ser.No. 10/242,976, filed Sep. 13, 2002, which applications are incorporatedby reference herein in their entirety.

BACKGROUND OF THE INVENTION

Medical devices for injecting fluids into a patient are well known inthe art. One such type of device is generally referred to as implantedports, which can be implanted subcutaneously in a patient. Various typesof ports can be used to provide access to the peritoneal cavity, as wellas the vascular, arterial, and epidural systems. The ports typicallyinclude a catheter for access to a large vein and a port body having aseptum, which is generally formed from silicone.

The port is implanted within a cavity formed in the patient, such as inthe chest area, and sutured to underlying tissue. From time to time, itis desirable to refill the port via the septum and/or provide anexternal source of fluid, e.g., IV access. One type of device used torefill an implanted port is generally known as a Huber needle. KnownHuber needles generally include a needle extending from a basestructure. With sufficient expertise and experience an operator, such asa nurse, can insert the needle into the port via the septum, which issliced (not cored) by the needle for self-sealing. The Huber needle canthen be taped to the patient and fluid delivered to the patientintravenously as desired via a coupled to the Huber needle device.

However, conventional Huber device can be relatively difficult to removefrom the patient. An operator may need to apply a significant amount offorce to initiate removal of the device. If the needle suddenlyreleases, the operator may be accidentally injured by the needle as itis uncontrollably freed from the patient. In addition, even after saferemoval, known Huber needle devices can present a hazard due to theoutwardly extending needle.

It would, therefore, be desirable to overcome the aforesaid and otherdisadvantages.

SUMMARY OF THE INVENTION

The present invention provides a medical device, such as a Huber needle,having a needle and a structure that enhances user safety during removalof the needle from a patient. The inventive structure reduces thelikelihood that medical personnel will suffer injury from the needle asit is forcibly removed from the patient. While the invention isprimarily shown and described in conjunction with a Huber-type needle,it is understood that the invention is applicable to devices in generalin which it is desirable to reduce the possibility of injury from aneedle.

In one aspect of the invention, a medical device includes a centralstructural member from which a needle extends. At least one wing portionextends from the central structural member for facilitating removal ofthe needle from the patient in a controlled manner. A base member forcontacting the patient's skin is coupled to the central structuralmember. First and second members are pivotably secured to the basemember so as to provide a structure that can be transitioned from a useposition in which the needle extends from the device for insertion intothe patient and a non-use position in which the needle is captured bythe first member as the needle is extracted from the patient.

With this arrangement, an operator leverages pressure applied to thewing portion(s) with a finger(s) and counter pressure on the firstmember so as to enable a controlled removal of the needle from thepatient. In addition, the collapsible/expandable structure captures theneedle in the first member as it is removed from the patient to enhanceoperator safety.

In another aspect of the invention, a medical device has a use positionand a non-use position with a housing having first and second portionseach having respective first and second ends. The second portion has afirst position in the use position and a second position in the non-useposition. A longitudinal member has first and second ends and extendsfrom the housing in the use position. In the non-use position, thelongitudinal member is captured by the first housing portion. A needleextends from the device in the use position and envelops the device thenon-use position. The device can include one or more locking mechanismsto secure the device in the non-use position.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIGS. 1A and 1B are perspective schematic depictions of a medical devicehaving enhanced safety in accordance with the present invention in thenon-use position;

FIG. 2A is a perspective schematic depiction of the medical device ofFIG. 1 in the non-use position;

FIG. 2B is a perspective schematic depiction of the medical device ofFIG. 2A in a use position;

FIG. 2C is a bottom perspective view of the device of FIG. 2B;

FIG. 3A is a perspective schematic depiction of a medical device havingenhanced safety in accordance with the present invention in a non-useposition;

FIG. 3B is a perspective schematic depiction of the medical device ofFIG. 3A in the use position;

FIG. 4A is a perspective schematic depiction of an exemplary medicaldevice having enhanced safety in accordance with the present inventionshown in a non-use position;

FIG. 4B is a top view of the device of FIG. 4A;

FIG. 4C is a sectional view of the device of FIG. 4B;

FIG. 5A is a top view of the exemplary medical device of FIG. 4A shownin a use position; and

FIG. 5B is a sectional view of the device of FIG. 5A along line 5B.

FIG. 6 is a perspective schematic representation of an exemplary medicaldevice shown in a use position in accordance with the present invention;

FIG. 7A is a top view of the medical device of FIG. 6;

FIG. 7B is a side view of the medical device of FIG. 6;

FIG. 7C is a bottom view of the medical device of FIG. 6;

FIG. 7D is a cross-sectional view along line 7D of the medical device ofFIG. 7B;

FIG. 8A is a top view of the medical device of FIG. 6 in a non-useposition;

FIG. 8B is a side view of the medical device of FIG. 6 in a non-useposition; and

FIG. 8C is a front view of the medical device of FIG. 6 is a non-useposition.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1A-1B show a medical device 100 including a needle 102 and astructure for enhanced operator safety in accordance with the presentinvention. In general, the device structure facilitates removal of theneedle from a patient and captures the needle as it is retracted fromthe patient's body. During use, the device is relatively flat orcollapsed and the needle extends outwardly for insertion into animplanted port device, for example. After use, the device istransitioned to the non-use position in which the needle is capturedwithin the device. As described below, the device can include variousfeatures to prevent a transition to the use position from the non-useposition to preclude re-use of the device.

The device 100 includes opposed first and second wing portions 104 a,bextending from a central structural member 106. As described below, thewing portions 104 provide surfaces on which an operator can applypressure to insert the device. This arrangement leverages the forceapplied to the device so as to provide smooth, and safe, insertion andextraction of the needle from the patient.

FIGS. 2A-2C show further details of an exemplary medical device 100′having a structure providing enhanced safety features in accordance withthe present invention. In general, the device of FIGS. 1A and 1B issimilar to the device of FIGS. 2A-2C in which like referencedesignations indicate like elements. The device 100 includes a series ofinterconnected members that move with respect to the central structuralmember 106 for safely transitioning the device from use position to thenon-use position. The various members shown in FIGS. 2A and 2B aremarked with a particular shape as shown to designate the correspondingparts on each of these figures.

A first member 110 is pivotably coupled to a skin-contacting base member108 at a pivot 112. In an exemplary embodiment, the first member 110includes an arcuate portion 110 a for accommodating the stacked membersin the use position, as best shown in FIG. 2B. A second member 114, atrespective pivots 116, 118, extends between the base member 108 and thefirst member 110. In one embodiment, the second member 114 includesfirst and second sub portions 114 a,b joined at a pivot point 120 toenable the second member first and second sub portions 114 a,b to foldunder the first member 110. It is understood that these members havemirror images on each side of the central structural member 106.

The device further includes a raised portion 122 that can form a part ofthe first member 110. As shown in FIGS. 2A and 2B, the raised portion122 can include a depression 124 that can be pressured by an operator'sthumb, for example, to insert the device into the patient. As usedherein, the use position refers to the needle outwardly extending fromthe device for insertion into a patient. In the use position, the deviceis “flat” or collapsed.

As shown in FIGS. 2B and 2C, (and 4C and 5B) for example, the centralstructural member 106 can include a slotted channel 126 from which theneedle extends perpendicularly, for example. The needle 102 can have anL-shape to facilitate coupling of the needle with a tube (not shown)disposed within the channel 126. The needle can be secured within thechannel 126 in a conventional manner, such as by adhesive.

The device can include various features to improve the operation andsafety of the device. For example, the device can include one or morelatches to further enhance operator safety.

As shown in FIGS. 3A-3B, the device can include a first latchingmechanism 150 located at an end of the first member 110. In oneparticular embodiment, the first latching mechanism includes a tab 152to facilitate detachment of a latch member 150 a from a receivingaperture or cutout 150 b in the central structural member 106. Thelatching mechanism 150 can be released to raise the first member 110 bylifting the tab 152 prior to removal of the device from the patient.

A second latch 180 shown in FIGS. 3A (and 4C) for example, can belocated at a tip of the first member 110 so that the needle is retainedwithin the first member. In an exemplary embodiment, the needle 102 iscaptured by an arcuate cavity 182 formed in the first member 110. Oncethe device transitions to the non-use position, the second latch 180prevents the device from transitioning to the use position by retainingthe needle within the cavity.

In another embodiment (not shown), the device can include mechanisms toprovide unidirectional movement to the non-use position. In oneembodiment, the first member includes a ratchet-type device allowingonly movement of the first member 110 away from the base member 108.

Referring again to FIGS. 2A-3B, the structure of the device 100leverages the force applied to the wing portions 104 and the firstmember 110 to ease extraction of the needle from the patient. In oneembodiment, while the device is flush with the patient's skin, theoperator moves the first member 110 to an upright position with respectto the central structural member 106. The operator then applies firstand second fingers underneath the wing portions 104 and a thumb, forexample, on or near the tab 152 of the first member 110. By applyingforce on top of the upright first member 110, the implanted port isstabilized in position. The operator can then apply force to lift thewing portions 104 up while applying a counter-force on the first member110 to leverage the force applied on the wing portions.

The applied pressure forces the central structural member 106 and wings104 up and away from the base member 108 and the needle 102 retractsinto the cavity 182 in first member 110. With this arrangement, it isrelatively easy for the operator to apply steady pressure to the devicefor a smooth extraction of the needle from the patient. That is, theneedle is not suddenly freed from the patient in a relatively out ofcontrol manner. It is understood that the tab 152 can be shaped tofacilitate movement of the first member 110 to an upright position andto accommodate force applied to the tab 152 by the operator's thumb.

FIGS. 4A-5B show further details of a Huber needle-type device, such asthe device 100 of FIGS. 1A and 1B, having enhanced safety features inaccordance with the present invention. FIGS. 4A-4C show a device in thenon-use position from a perspective, top, and sectional view,respectively. FIG. 5A is a top view of a device in the use position inaccordance with the present invention and FIG. 5B is a sectional viewtaken along line 5B of FIG. 5A.

In one embodiment, the devices can be delivered in the use position. Asdescribed above, the devices can include various features to prevent atransition from the use position to the non-use position.

In a further aspect of the invention shown in FIG. 6, a medical device200, which is shown in a user position, includes a longitudinal member202 that slides into a housing 204. In an exemplary embodiment, thedevice 200 locks in a non-use position after removal of a needle 206from a patient. In general, when the device 200 is in the use position,a user can apply finger pressure to first and second wing portions 208a,b and thumb pressure to an end 202 a of the longitudinal member toforce retraction of the needle 206 from the patient's body. When thelongitudinal member 202 is captured by the housing 204, the needle 206no longer protrudes from the device 200 to enhance operator safety.

FIGS. 7A-8C show further details of the device 200 shown in FIG. 6.FIGS. 7A-7D show the device 200 in a first or use position and FIGS.8A-8C show the device 200 in a second or non-use position. A user oroperator transitions the device 200 from the use position to the non-useposition as described in detail below.

As shown in FIGS. 7A-7D, in the use position the needle 206 protrudesfrom the device 200 for insertion into a patient. The device 200 isrelatively flat in the use position so that a bottom surface 210 canrest on a patient while the needle 206 is disposed beneath the skin. Theextended longitudinal member 202 includes a channel 212, which can becentered about a longitudinal axis 214 of the device. The needle 206extends through the channel, which allows axial movement of thelongitudinal member. The longitudinal member 202 further includes afirst and optional second locking mechanism 216 a, 216 b for securingthe longitudinal member 202 in the non-use position, as described morefully below.

In an exemplary embodiment, the housing 204 include first and secondportions 204 a, 204 b that are secured to each other. In one embodiment,one end of the second housing portion 204 b is coupled to one end of thelongitudinal member 202 and the other end of the second housing portionis coupled to an end of the first housing portion 204 a. Optional firstand second wing portions 208 a, 208 b extend from the housing firstportion 204 a. The wing portions 208 can be arcuate as shown to receive,for example, the application of force by the index and middle fingers ofa user.

A needle retaining member 218 is disposed on the housing 204 forsecuring the needle 206, which extends through the channel 212, in thelongitudinal member 202. The arrangement of the channel 212 and theneedle retaining member 218 secures the needle in position while notinterfering with movement of the longitudinal member 202 duringtransition of the device from the use position to the non-use position.

In one embodiment, the housing 204 further includes first and secondlocking members 220 a, 220 b that mechanically communicate with thefirst and second locking members 216 a, 216 b of the longitudinal member202. In general, upon complete insertion of the longitudinal member 202into the housing 204, the housing locking members 220 align andinterlock with the longitudinal member locking members 216. In thenon-use position, the longitudinal member 202 cannot be removed from thehousing 204 to prevent re-use of the device and promote user safety.

FIGS. 8A-8C show the medical device 200 in the non-use position with thelongitudinal member 202 fully inserted into housing 204 and the lockingmembers 216, 220 engaged. The second housing portion 204 b includes afirst piece 222 a, and a second piece 222 b that can pivot with respectto each other. In the non-use position, the first and second pieces 222form an angle of about ninety degrees in one particular embodiment. Theangled first and second pieces 222 extend outwardly from the firsthousing portion 204 a so as to envelope the needle 206. That is, in thenon-use position, the needle 206 does not protrude from the device 200.A slot 224 (FIG. 7C) in the second housing portion 204 a enables thefirst and second pieces 222 to pivot unencumbered by the needle 206.

In one particular embodiment, the non-pivoting end of the first piece222 a is coupled to the end 202 a of the longitudinal member. As forceis applied to the longitudinal member 202 to force it into the housing204, movement of the longitudinal member 202 pivots the first piece 222a with respect to the second piece 222 b. The non-pivoting end of thesecond piece 222 b is coupled to an end of the first housing portion 204a.

In an exemplary embodiment, the second housing portion 204 b includes aseries of ribs to create friction as the device 200 transitions to thenon-use position during extraction of the needle 206 from the patient.As force is applied to the longitudinal member 202, the pivoting firstand second pieces 222 push against the patient to withdraw the needle206.

It is understood that the device dimensions can vary to meet the needsof a particular application. In one embodiment, the device has a lengthof about 2.3 inches and a height of about 1.5 inch in the non-useposition. The device can have a width measure from ends of the wingportions of about 2.1 inches.

The inventive medical device shown and described herein can befabricated from a variety of suitable materials well known to one ofordinary skill in the art. Exemplary materials include plastic, such asPVC, polyethylene, and the like.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

What is claimed is:
 1. A medical device having a use position and anon-use position, comprising: a housing having first and second housingportions and first and second locking members, the first and secondhousing portions each having respective first and second ends, and thesecond housing portion having a first position in the use position and asecond position in the non-use position, wherein the second housingportion includes pivotably coupled first and second pieces such that thefirst and second pieces are generally planar in the use position andpivot to the non-use position; a longitudinal member having first andsecond ends and first and second locking members, the longitudinalmember extending from the housing in the use position and captured bythe housing in the non-use position, wherein pressure on the first endof the longitudinal member toward the housing causes the first andsecond pieces of the second housing portion to pivot away from thelongitudinal member to the non-use position, and wherein the housinglocking members mechanically communicate with the longitudinal memberlocking members such that upon substantially complete insertion of thelongitudinal member into the housing in the non-use position, thehousing locking members substantially align and interlock with thelongitudinal member locking members to substantially secure thelongitudinal member to the housing; and a needle extending from thedevice in the use position and not extending from the device in thenon-use position, wherein the needle is captured by the housing in thenon-use position.
 2. The device according to claim 1, wherein the firstend of the longitudinal member is coupled to the first end of the secondhousing portion.
 3. The device according to claim 2, wherein the secondend of the first housing portion is coupled to the second end of thesecond housing portion.
 4. The device according to claim 1, wherein thesecond housing portion includes a slot for enabling transition of thedevice from the use position to the non-use position unencumbered by theneedle.
 5. The device according to claim 4, further including first andsecond wing portions extending from the housing to receive fingerpressure from a user to transition the device from the use position tothe non-use position.
 6. The device according to claim 1, wherein thelongitudinal member includes a channel to enable longitudinal movementof the longitudinal member unimpeded by the needle, wherein the needleextends through the channel.
 7. The device according to claim 6, whereinthe housing includes a needle retaining member to secure the needle inposition in the longitudinal member.
 8. The device according to claim 7,wherein the second housing portion includes a slot to enable atransition to the non-use position free of interference from the needle.9. The device according to claim 7, further including first and secondwing portions extending from the housing for receiving pressure from auser to promote transition of the device to the non-use position. 10.The device according to claim 9, wherein the first and second wingportions extend from the first housing portion and have an arcuateshape.
 11. The device according to claim 1, wherein the longitudinalmember slides into the housing.
 12. The device according to claim 1,wherein the first and second pieces of the second housing portion pushthe device away from a patient in response to the pressure on the end ofthe longitudinal member as the device transitions from the use positionto the non-use position.
 13. The device according to claim 1, whereinthe longitudinal member slides into the housing in the non-use position.14. The device according to claim 1, wherein the first and second piecesof the second housing portion form an angle of about ninety degrees inthe non-use position.
 15. The device according to claim 1, wherein thefirst and second pieces of the second housing portion each have a firstend that pivots relative to other piece of the second housing and asecond end, wherein the second end of the first piece is coupled to thefirst end of the longitudinal member and the second end of the secondpiece is coupled to the second end of the first housing portion.
 16. Thedevice according to claim 1, wherein the second housing portion includesa series of ribs to create friction as the device transitions to thenon-use position.
 17. The device according to claim 1, wherein thedevice has a length of about 2.3 inches and a height of about 1.5 inchin the non-use position.
 18. The device according to claim 1, whereinthe device is fabricated from a plastic material.
 19. A method ofproviding safety in medical device having a use position and a non-useposition, comprising: providing a housing for receiving a longitudinalmember having first and second ends, first and second locking members,and a channel, the housing having first and second housing portions andfirst and second locking members, the first and second housing portionseach having first and second ends; connecting the first end of the firsthousing portion to the first end of the longitudinal member; connectingthe second end of the first housing portion to the second end of thesecond housing portion; and affixing a needle to the device extendingfrom the first housing portion through the channel in the use position;wherein axial pressure at the first end of the longitudinal membertoward the housing in the use position forces the first and secondhousing portions to pivot and extend from the first housing portion andenvelop the needle, and wherein the housing locking members mechanicallycommunicate with the longitudinal member locking members such that uponsubstantially complete insertion of the longitudinal member into thehousing in the non-use position, the housing locking memberssubstantially align and interlock with the longitudinal member lockingmembers to substantially secure the longitudinal member to the housing.20. The method according to claim 19, further including coupling firstand second wing portions to the housing to receive finger pressure froma user to transition the device to the non-use position.
 21. A method ofremoving a medical device needle from a patient and transitioning thedevice from a use position to a non-use position, comprising:pressuring, in the use position, an end of a longitudinal member towarda housing, wherein the longitudinal member has first and second ends,first and second locking members, and a channel into the housing havingfirst and second portions and first and second locking members, thefirst and second housing portions each having first and second ends suchthat the first and second portions extend at a pivot point to envelop aneedle of the device as the device transitions to the non-use position,wherein the housing locking members mechanically communicate with thelongitudinal member locking members such that upon substantiallycomplete insertion of the longitudinal member into the housing in thenon-use position, the housing locking members substantially align andinterlock with the longitudinal member locking members to substantiallysecure the longitudinal member to the housing.
 22. The method accordingto claim 21, wherein the pivot point pushes the needle out of apatient's body.
 23. A medical device, comprising: a housing having firstand second housing portions and first and second locking members, thefirst housing portion having first and second ends and the secondhousing portion having first and second ends, the second housing portionhaving pivotably coupled first and second pieces, the first housingportion extending along an axis; a longitudinal member having first andsecond ends, a channel, and first and second locking members, thelongitudinal member being movable from a use position in which thelongitudinal member is extended from the housing along the axis and anon-use position in which the longitudinal member is captured by thefirst housing portion by pressuring the second end of a longitudinalmember toward a housing, the first end of the second housing portionbeing connected to the first end of the longitudinal member and thesecond end of the first housing portion being connected to the secondend of the second housing portion; and a cavity arrangement formed inthe housing portion, wherein the cavity arrangement is dimensioned toreceive one or more needles, wherein the housing locking membersmechanically communicate with the longitudinal member locking memberssuch that upon substantially complete insertion of the longitudinalmember into the housing in the non-use position, the housing lockingmembers substantially align and interlock with the longitudinal memberlocking members to substantially secure the longitudinal member to thehousing.
 24. The device according to claim 23, wherein the cavityarrangement is substantially arcuate.
 25. The device according to claim23, wherein the cavity arrangement enables an operator to apply steadypressure to the wing portions and the first member to ease extraction ofthe needle from the patient.
 26. The device according to claim 23,wherein the needle is captured within the cavity arrangement when thedevice is transitioned to the non-use position.